BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2073147 · Received April 29, 2011

    Report

    Report Number
    3005075853-2011-01804
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    November 26, 2010
    Report Date
    April 28, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT PROVIDED ON INITIAL CONTACT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED WITH THE BLADE SCRATCHED AND CRACKED. THE INSTRUMENT DID NOT HAVE A BROKEN BLADE WHEN RECEIVED. IT IS POSSIBLE THAT THE DEVICE RETURNED MAY HAVE BEEN USED TO COMPLETE THE PROCEDURE AND IS NOT THE DEVICE COMPLAINED ABOUT. DURING FUNCTIONAL TESTING, AN ERROR CODE 5 WAS DISPLAYED AND THE BLADE TIP FURTHER CRACKED. THE DEVICE WILL STOP ACTIVATING, AND EITHER EMIT A SOLID TONE OR DISPLAY AN INSTRUMENT ERROR CODE 5 ON THE GENERATOR DISPLAY WHEN THE BLADE BECOMES DAMAGED. WHEN A BLADE HAS BEEN COMPROMISED SUCH AS SCRATCHED OR CRACKED, THE TITANIUM METAL IS FATIGUED WHEN CONTINUALLY ENERGIZED AND THIS RESULTS IN THE BLADE FURTHER CRACKING AND POSSIBLY BREAKING OFF. A PROBABLE CAUSE OF AN ERROR CODE 5 (INSTRUMENT ERROR) IS BLADE DAMAGE. BLADE DAMAGE MAY OCCUR FROM EXTERNAL CONTACT WITH METAL OR PLASTIC DURING PRE-OP OR GENERAL USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC RECTOSIGMOIDECTOMY TO DEEP ENDOMETRIOSIS PROCEDURE, THE SHEARS PRESENTED THE BREAK OF THE ACTIVE SPADE BEING WITH THAT NECESSARY THE EXCHANGE OF THE SHEARS FOR THE CONCLUSION OF THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE